Main randomised controlled trials focusing on pleurodesis for the management of malignant pleural effusions
| Trial | Year | Country | First author [ref.] | Treatment arms | Summary of findings |
|---|---|---|---|---|---|
| TAPPS | 2020 | UK | Bhatnagar [13] | Talc poudrage versus talc slurry pleurodesis | No significant difference in pleurodesis failure at 90 days between talc poudrage and talc slurry pleurodesis (22% and 24%, respectively; OR 0.91 (95% CI 0.54–1.55), p=0.74) No differences in pleurodesis failure at 180 days (29% versus 29% in poudrage and slurry, respectively; OR 1.05 (95% CI 0.63–1.73), p=0.86) No differences in mean number of nights in hospital (12 versus 11 nights in poudrage and slurry, respectively; p=0.35) No differences in all-cause mortality at 180 days (40% and 42% for poudrage and slurry, respectively; p=0.70) Adverse events were comparable between the two arms (29% versus 28% in poudrage and slurry arms, respectively (OR 1.05 (95% CI 0.63–1.73), p=0.86) |
| IPC-PLUS | 2018 | UK | Bhatnagar [33] | Talc slurry pleurodesis or placebo instilled via IPC on an outpatient basis | Talc pleurodesis was associated with a significantly higher probability of pleurodesis (success rates of 43% in the talc group versus 23% in the placebo group; HR 2.20 (95% CI 1.23–3.92), p=0.008) No significant differences in effusion size and complexity, number of inpatient days, mortality or number of adverse events were found No significant excess of obstructions of the IPCs was found in the talc group |
| TIME2 | 2012 | UK | Davies [16] | Talc slurry pleurodesis versus IPC placement alone | Dyspnoea improved in both groups without a significant difference in the first 42 days (mean VAS dyspnoea score of 24.7 mm in the IPC group (95% CI 19.3–30.1 mm) versus 24.4 mm (95% CI 19.4–29.4 mm) in the talc group; difference of 0.16 mm (95% CI −6.82–7.15), p=0.96) A statistically significant improvement in dyspnoea for patients with IPCs was observed at 6 months (mean VAS score difference between the IPC and talc groups of −14.0 mm (95% CI −25.2– −2.8 mm), p=0.01) Hospitalisation duration was significantly shorter in the IPC group (difference of −3.5 days (95% CI −4.8– −1.5 days), p<0.001) |
| AMPLE | 2017 | Australia New Zealand Singapore Hong Kong | Thomas [44] | Talc slurry pleurodesis versus IPC placement alone | Lower hospitalisation length in the IPC group (median 10.0 days (IQR 3–17 days) in IPC group versus 12.0 days (IQR, 7–21 days) in pleurodesis group, p=0.03; Hodges–Lehmann estimate of difference 2.92 days (95% CI 0.43–5.84 days) Fewer patients in IPC group required further pleural drainages (4.1% versus 22.5%; difference 18.4% (95% CI 7.7–29.2%)) No significant differences in improvements in breathlessness, quality of life or adverse events |
| OPTIMUM | 2023 | UK | Sivakumar [45] | Talc pleurodesis following IPC placement of classical chest drain | No significant difference at day 30 (mean intergroup difference in baseline-adjusted global health status of 2.06 (95% CI −5.86–9.99), p=0.61), day 60 or day 90 No significant differences in breathlessness and chest pain scores Pleurodesis failure was significantly higher in the IPC arm than in the chest drain arm (69% versus 26.5% at 90 days, respectively) |
| ASAP | 2017 | UK USA | Wahidi [23] | Daily drainage versus every other day drainage of pleural fluid via an IPC | Rate of autopleurodesis was higher in the aggressive drainage arm than the standard drainage arm (47% versus 24%, respectively; p=0.003) Median time to autopleurodesis was shorter in the aggressive arm (54 days (95% CI 34–83 days) versus 90 days (95% CI 70–nonestimable) Rate of adverse events, quality of life and patient satisfaction were not significantly different |
IPC: indwelling pleural catheter; HR: hazard ratio; VAS: visual analogue scale; IQR: interquartile range.